On the subject of the SAP, I would think the company is trying to develop a single document acceptable to all four regulatory agencies, but I wonder if people think they may need separate documents for each regulator. I would suspect that getting all to agree on the same document may be what's taking so much time.
I believe it's not a case of gaining regulatory approval of a draft, but rather having changes suggested. If language is changed to something suggested by say Germany, it's possible another regulator won't like it if they passed on the language that previously existed.
There may be a point where they just submit what they have, even if it hasn't been fully concurred with by all four regulators. Whether it is, or isn't, it's the data that should establish approval. If the data clearly demonstrates that the vaccine should be approved, even if it fails to meet all provisions of the SAP it has a good potential to be approved. Of course it's very possible that one regulator will want more, while others approve. It's not unusual for products to be available in one part of the world, and not in others. Frequently it's the U.S. that's the odd man out, and patients with means travel elsewhere to gain access to drugs not available in the U.S.
60 Minutes did a great story some time ago on top flight hospitals largely establish by American Doctors in foreign nations so the Doctors would have access to drugs not yet available in the U.S. For those who choose treatment in these hospitals, they not only had great medical care, they also got great food, and they recovered in world class resorts prior to release.
I hope the new fires in the L.A. area don't have anyone at risk. I have friends living near where some of these are occurring, but don't believe any are in immediate risk. Serious winds are supposed to be hitting here from Tuesday to Thursday are supposed to be worse, so it's far from being over.
Gary
